U.S. patent application number 10/584399 was filed with the patent office on 2008-02-14 for heating type balloon catheter device, and elastic tube device and vibrator device for the catheter device.
This patent application is currently assigned to NIHON MEDIX Co., Ltd.. Invention is credited to Kazunari Hasebe.
Application Number | 20080039790 10/584399 |
Document ID | / |
Family ID | 34746872 |
Filed Date | 2008-02-14 |
United States Patent
Application |
20080039790 |
Kind Code |
A1 |
Hasebe; Kazunari |
February 14, 2008 |
Heating Type Balloon Catheter Device, and Elastic Tube Device and
Vibrator Device for the Catheter Device
Abstract
An elastic tube (40) is connected to the base end portion of a
catheter main body (1) having a balloon (2) at its top end portion.
When the elastic tube (40) is set at a vibrator device (RP), the
end portion side of the elastic tube, projecting outside, works as
a margin volume part (40A). A roller (53) of the vibrator device
(RP) can have a shut-off state where the elastic tube (40) is
pressed and completely closed, and a communication state where the
elastic tube cannot be pressed. When the roller (53) is rotated in
a predetermined direction with the inside of a route from the
balloon (2) up to the elastic tube (40) filled up with a liquid for
heating, the liquid in the elastic tube (40) is pressed toward the
margin volume part (40A) in the shut-off state, while in the
communication state, the pressurized heating liquid in the margin
volume part (40A) flows backward to the balloon (2) side. Repeating
the pressurizing and the backward flow vibrates the heating liquid
in the balloon (2). When the balloon (2) is larger, the length (V)
of the margin volume part (40A) is made longer, so that an adequate
level of vibration in accordance with the size of the balloon (2)
can be applied.
Inventors: |
Hasebe; Kazunari;
(Matsudo-shi, JP) |
Correspondence
Address: |
MORRISON & FOERSTER LLP
1650 TYSONS BOULEVARD, SUITE 400
MCLEAN
VA
22102
US
|
Assignee: |
NIHON MEDIX Co., Ltd.
Matsudo-shi
JP
|
Family ID: |
34746872 |
Appl. No.: |
10/584399 |
Filed: |
January 29, 2004 |
PCT Filed: |
January 29, 2004 |
PCT NO: |
PCT/JP04/00816 |
371 Date: |
June 4, 2007 |
Current U.S.
Class: |
604/113 |
Current CPC
Class: |
F04B 43/1253 20130101;
A61B 18/04 20130101; A61B 2018/00011 20130101; A61B 2018/00023
20130101; A61B 2018/046 20130101; A61B 2018/0022 20130101; F04B
43/0072 20130101 |
Class at
Publication: |
604/113 |
International
Class: |
A61F 7/12 20060101
A61F007/12 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 26, 2003 |
JP |
2003-432986 |
Claims
1. A heating-type balloon catheter device having a heating-type
balloon at a top end portion of a catheter main body and a
vibration imparting device connected to a base end portion of the
catheter main body and disposed to impart vibration to a liquid for
heating in the heating-type balloon through a liquid for heating
filled in the catheter main body; said vibration imparting device
comprising: an elastic tube with a base end portion thereof
connected to said catheter main body and with a top end portion
thereof closed, said elastic tube being filled with a liquid for
heating; and a vibrator device having a roller rotating about a
rotary shaft at a position offset to the rotary shaft and set to
the elastic tube; wherein said elastic tube is set to said vibrator
device in such a manner that a predetermined direction of rotation
of said roller extends from the side of the base end portion of
said elastic tube to the side of the top end portion thereof and a
margin volume part which is not pressed with said roller is
provided on the side of the top end portion of said elastic tube;
and wherein said elastic tube is disposed to assume a shutt-off
state and a communication state in accordance with rotation of said
roller in its predetermined direction, the shutt-off state being a
state in which the base end portion side of said elastic tube and
the top end portion side thereof are blocked by pressing said
elastic tube with the roller and reducing a radial size of said
elastic tube with the roller and the communication state being a
state in which the base end portion side of said elastic tube is
communicated with the top end portion side thereof by enlarging and
recovering the size of said elastic tube due to elasticity by
releasing the pressing of said elastic tube with the roller; and
wherein the heating liquid in said elastic tube is supplied with
pressure toward said margin volume part when said elastic tube is
in the shutt-off state while the heating liquid pressurized in said
margin volume part is flown backward toward the base end portion
side of said elastic tube when said elastic tube is in the
communication state, in accordance with rotation of the roller in
the predetermined direction of rotation of the roller.
2. The heating-type balloon catheter device as claimed in claim 1,
wherein said elastic tube is connected to the base end portion of
said catheter main body through an extension tube which is superior
in rigidity and unlikely to be deformed by expansion and
constriction in a radial direction thereof.
3. The heating-type balloon catheter device as claimed in claim 1,
wherein: a connecter having plural branch passages is fitted to the
base end portion of said catheter main body; and said elastic tube
is connected to a predetermined branch passage for supplying a
contrast agent, among the plural branch passages.
4. The heating-type balloon catheter device as claimed in claim 3,
wherein: said elastic tube is connected to the predetermined branch
passage through a shift valve; and said shift valve is set to
assume a first shift position for supplying the catheter main body
with a contrast agent by blocking a communication between said
elastic tube and said catheter main body and a second shift
position for communicating said elastic tube with said catheter
main body.
5. The heating-type balloon catheter device as claimed in claim 1,
wherein an indicator is provided on an outer peripheral surface of
said elastic tube, which indicates a size of said margin volume
part to be set in accordance with a size of said balloon.
6. The heating-type balloon catheter device as claimed in claim 5,
wherein said indicator is set on the basis of a predetermined
position of a housing of said vibrator device.
7. The heating-type balloon catheter device as claimed in claim 6,
wherein: the predetermined position of the housing is set to a
position which is located on an orifice edge surface on an outlet
side of the housing or in the vicinity thereof and which is readily
visible from outside, and said indicator is formed in plural
numbers at spaced intervals in an area extending from the top end
portion side of said elastic tube to the base end portion side
thereof.
8. The heating-type balloon catheter device as claimed in claim 1,
wherein at least one air vent valve for withdrawing air in a
predetermined path is disposed on the predetermined path extending
from the base end portion of said catheter main body to the top end
portion of said elastic tube.
9. The heating-type balloon catheter device as claimed in claim 8,
wherein said air vent valve is connected to the top end of said
elastic tube.
10. The heating-type balloon catheter device as claimed in claim 8,
wherein said air vent valve comprises a first air vent valve
connected to a path extending from said catheter main body to said
elastic tube and a second air vent valve connected to the top end
of said elastic tube.
11. An elastic tube device comprising an elastic tube which is
expanded or constricted in such a manner that tube walls of said
elastic tube opposite to each other are caused to be closely
attached to each other in a radial direction upon application of
external force toward a direction in which the elastic tube is
closed and that they are allowed to recover to its original size
due to its own elasticity when the external force is released;
wherein said elastic tube has the top end closed and the base end
portion constituting a connection part to a catheter main body; and
wherein a plurality of indicators are disposed on an outer
peripheral surface of said elastic tube at a spaced interval in a
longitudinal direction of the elastic tube, said indicators
corresponding to a size of a balloon in a heating-type balloon
catheter device .
12. The elastic tube device as claimed in claim 11, wherein said
indicators are formed from the top end portion side of said elastic
tube to the base end portion side thereof.
13. The elastic tube device as claimed in claim 11, wherein an air
vent valve for selectively opening said elastic tube to the
atmosphere is connected to either one of the top end and the base
end of said elastic tube.
14. The elastic tube device as claimed in claim 11, wherein an air
vent valve for selectively opening said elastic tube to the
atmosphere is connected each to the top end portion of said elastic
tube and the base end portion thereof.
15. A vibrator device comprising: a housing; a rotary shaft held
pivotally to the housing; a guide surface formed in an arc shape
about said rotary shaft on an inner peripheral surface of said
housing in a manner as winding said rotary shaft; and a roller for
pressing an elastic tube in cooperation with the guide surface,
which rotates about said rotary shaft at a position offset from
said rotary shaft; wherein a number and/or disposition of said
roller are/is disposed to assume a state in which the roller is not
opposite to the guide surface and does not press said elastic tube
as the rotary shaft makes a full revolution.
16. The vibrator device as claimed in claim 15, wherein: said
roller comprises only one roller; and a length of said guide
surface is set to be at an angle in the range of approximately 180
degree about said rotary shaft.
17. The vibrator device as claimed in claim 15, wherein: said
roller comprises two rollers disposed at an interval of 180 degree
about said rotary shaft; and said guide surface is set to be at an
angle in the range of approximately 60 degree about said rotary
shaft.
18. The vibrator device as claimed in claim 15, wherein: said
roller comprises a front roller disposed at a position on the
advance side in a predetermined direction of rotation about said
rotary shaft and a rear roller disposed at a position on the delay
side in the predetermined direction of rotation; the front roller
and the rear roller are disposed in positions each in the proximity
to a direction of rotation of said rotary shaft and they are
disposed to assume a position at which each of the front and rear
rollers is opposite to the guide surface and a position at which
each of them is not opposite to the guide surface, as the rotary
shaft makes a full revolution in the predetermined direction of
rotation thereof; and a spaced distance between said front and rear
rollers is set to become somewhat larger than a spaced distance
between said front roller and said guide surface as said front
roller and said rear roller are opposite to the guide surface.
Description
TECHNICAL FIELD
[0001] The present invention relates to a heating-type balloon
catheter device designed to make the temperature of heating liquid
in a balloon uniform by utilizing vibration of the heating liquid,
as well as an elastic tube device and a vibrator device for use
with the catheter device.
BACKGROUND ART
[0002] A balloon catheter which is fitted with a balloon at a
distal top end portion of the main body of the catheter is provided
therein with a heating means. The heating liquid filled in the
balloon is heated with the heating means, and the heated balloon is
brought into contact with the body tissues, thereby locally
cauterizing and consequently treating the body tissues. The balloon
is further provided with a thermocouple acting as a thermosensor
for detecting the temperature of the heating liquid.
[0003] The heating-type balloon catheter device is desired in some
cases to be used for cauterizing a considerably wide area of the
body tissues with the balloon. To be more specific, for instance,
if an abnormal path (an accessory conduction passage) would exist
over a passage of electrical signals for moving the heart, it may
cause symptoms such as vertigo and sick sensation which are
referred to as atrial fibrillation. The atrial fibrillation may
further cause the deterioration of cardiac incompetence or
constitute a serious cause for brain infarction. In order to cut
off the abnormal conduction path formed in the pulmonary vein, an
edge portion of the opening of the pulmonary vein opening toward
the left ventricle (the pulmonary vein orifice) is desirably
cauterized totally, i.e., in an annular fashion.
[0004] As described above, in the event where the heating liquid
filled in the balloon is heated while sustaining the temperature to
be detected with the thermocouple fitted in the balloon to a
predetermined temperature in a state in which the balloon is in
annular contact with the pulmonary vein as a whole, it has been
found that an event may be caused to occur where a state in which
the pulmonary vein is cauterized in a peripheral direction may vary
to a considerable extent. In other words, it has been found that
this event may lead to a state in which a certain portion of the
pulmonary vein orifice is over-heated while the other portion
thereof is heated to a lesser and insufficient level.
[0005] Japanese Patent Application Publication No. 2003-111,848
discloses the technique in which heating liquid filled in the
balloon is stirred by utilizing vibration in order to uniform the
temperature of the heating liquid in the balloon. More
specifically, the device of this type is constructured in such a
manner that a vibration imparting device for imparting vibration is
connected to the base end portion of a catheter main body and a
passage extending from the vibration imparting device to the
balloon is filled with the heating liquid so as to transmit the
vibration imparted with the vibration imparting device to the
heating liquid in the balloon through the heating liquid within the
catheter main body.
[0006] Some devices for imparting vibration are proposed, which
include a device of the type that utilizes a diaphragm drivable
reciprocally with a motor or a device of the type that expands or
contracts an elastic tube connected to the base end portion of the
catheter main body in its radial direction with a member drivable
reciprocally.
[0007] It is to be noted herein that the balloon having a different
size may be used selectively by complying with a variation in the
body size of a patient or a site of cauterization or the like. The
size of the balloon may be 20.sub..phi., 25.sub..phi.or
30.sub..phi. for example.
[0008] As described above, it has been found that, in the event
that the size of the balloon is varied, an undesirable deformation
in expansion and shrinkage of the balloon would be caused to occur
due to a difference in uniformity of the temperature of the heating
liquid in the balloon even if an equivalent or similar level of
vibration would be imparted to the vibration imparting device. In
other words, in the event that an appropriate level of vibration is
set to a smaller-sized balloon, the extent of vibration (e.g., the
extent of stirring) may be too small for a larger-sized balloon,
thereby resulting in the likelihood that the temperature of the
heating liquid within the balloon remains irregular. Conversely, in
the event that an appropriate level of vibration is set to a
larger-sized balloon, it is too large for a smaller-sized balloon,
thereby causing a repetition of expansion and shrinkage of the
balloon to a great extent. In other words, problems may likely
occur that the balloon is caused to come into contact with the site
of cauterization (if the balloon would expands too much), while the
balloon is positioned apart from the site of cauterization (if the
balloon would shrink too much).
[0009] The present invention has been completed with the above
situation taken into account and has the first object to provide a
heating-type balloon catheter device that can provide a balloon
with vibration having the magnitude appropriate for the size of the
balloon and that can thoroughly block a vibration site to which to
impart vibration and a contact site to be brought into contact with
a heating liquid.
[0010] The second object of the present invention is to provide an
elastic tube device for use with the heating-type balloon catheter
device of the present The third object of the present invention is
to provide a vibrator device for imparting an appropriate level of
vibration upon use with the heating-type balloon catheter device of
the present invention.
DISCLOSURE OF INVENTION
[0011] In order to achieve the first object as described above, the
present invention adopts the solution as will be described
hereinafter. The solution resides in that a heating-type balloon
catheter device is provided which comprises: [0012] a catheter main
body fitted at its top end portion with a heating-type balloon; and
[0013] a vibration-imparting device connected to a base end portion
of the catheter main body, the vibrator device being provided for
imparting vibration to a heating liquid filled in the heating-type
balloon through a heating liquid filled in the catheter main body;
[0014] wherein the vibration-imparting device comprises an elastic
tube in which the heating liquid is to be filled, the elastic tube
being connected at its base end portion to the catheter main body
and closed at its top end portion; and [0015] a vibrator device
having a roller rotatable around a rotary shaft at a position
offset with respect to the rotary shaft and being provided with the
elastic tube; [0016] wherein the elastic tube is provided with the
vibrator device in such a way that a predetermined direction of
rotation of the rotary shaft is set to be directed from the side of
the base end portion of the elastic tube toward the side of the top
end portion thereof and that a margin volume part is ensured on the
side of the top end portion of the elastic tube, which is
constructed so as not to be pressed with the roller; [0017] wherein
the elastic tube is structured to assume a shutt-off state and a
communication state in accordance with rotation of the roller in
the predetermined direction of rotation thereof in such a way that
the shutt-off state is set to a state in which the base end portion
of the elastic tube and the top end portion thereof are blocked by
constriction or decrease of a radial size of the elastic tube by
pressing the elastic tube with the roller in the predetermined
direction of rotation, and the communication state is set to a
state in which the base end portion thereof is communicated with
the top end portion thereof by expansion or increase of the reduced
radial size of the elastic tube due to elasticity of the elastic
tube by releasing the pressing of the roller upon the elastic tube;
and [0018] wherein, in accordance with the rotation of the roller
in the predetermined direction of rotation thereof, pressure is
applied to the heating liquid in the elastic tube toward the margin
volume part, one the one hand, during a period when the elastic
tube is in the shutt-off state, and the heating liquid to which
pressure is applied in the margin volume part is flown backward
toward the base end portion of the elastic tube, on the other hand,
during a period when the elastic tube is in the communication
state.
[0019] In accordance with the above solution, the heating liquid is
provided with pressure toward the margin volume part, on the one
hand, by pressing the elastic tube with the roller, that is, by
constricting or ecreasing the radial size of the elastic tube, and
the pressured heating liquid within the margin volume part is
allowed to flow backward toward the catheter main body side, i.e.,
the balloon side, on the other hand, by separating the roller apart
from the elastic tube, that is, expanding or increasing the radial
size of the elastic tube. The application of pressure and the
backward flow of the heating liquid may be performed at repeated
times in accordance with the rotation of the rotary shaft. In the
event where a larger-sized balloon is to be applied, the way of
setting the elastic tube to the roller-type vibrator device is
changed simply in such a manner that the margin volume part becomes
larger than the balloon being smaller in size. In other words, in
the event that the balloon is a larger one, the elastic tube can be
set to the roller-type vibrator device in such a manner that the
margin volume part becomes larger in volume while the balloon is
smaller in size. This setting permits an appropriate level of
vibration energy to be obtained in accordance with the size of the
balloon. It is further noted as a matter of course that the cycle
of vibration can be readily varied with the number of rotation of
the rotary shaft.
[0020] Moreover, as the roller-type vibrator device is separated
thoroughly from the heating liquid through the elastic tube, the
heating-type balloon catheter device according to the present
invention is advantageous from the point of view of
cleanliness.
[0021] In addition, as the vibrator device of the present invention
is of the type utilizing the rotary movement alone, the vibrator
devive can be made simpler in structure than the conventional one
that utilizes the reciprocal movement. Furthermore, the vibrator
device according to the present invention can be structured by
using a conventional roller pump in an efficient way.
[0022] The preferred embodiments on the premise of the
above-mentioned solutions are as described in claims 2 to 10. More
specifically, the elastic tube is connected to a base end portion
of the catheter main body through an extension tube which is
superior in rigidity and unlikely to be deformed by expanding or
constricting in a radial direction thereof (as described in claim
2). In this embodiment, the vibrator device can be fitted at a
position apart from the catheter main body. It is to be noted
herein as a matter of course that, as the extension tube is made of
a material unlikely to be deformed by expandubg or constricting,
the vibration is not caused to be damped at the extension tube
portion to a great extent.
[0023] To the base end portion of the catheter main body is a
connecter having a plurality of branch passages. The elastic tube
can be connected to a predetermined branch passage for supplying a
contrast agent, among the branch passages (as described in claim
3). In this embodiment, the vibration can be transmitted to the
balloon by effectively utilizing the branch passage for supplying
the contrast agent.
[0024] The the elastic tube is connected to the predetermined
branch passage through a shift valve that can assume a first shift
position and a second shift position, the first shift position
being structured to block the communication of the elastic tube
with the catheter main body in order to supply the catheter main
body with the contrast agent and the second shift position being
structured to communicate the elastic tube with the catheter main
body (as described in claim 4). In this embodiment, the shift valve
can easily shift the position from a state of supplying the
contrast agent to a state of imparting vibration and vice
cersa.
[0025] The elastic tube can be provided at an outer peripherical
surface thereof with an indicator indicating the size of the margin
volume part to be set in accordance with the size of the balloon
(as described in claim 5). In this embodiment, the indicator allows
an easy and optimum setting of the size of the margin volume part
in accordance with the size of the balloon.
[0026] The indicator can be set by setting a predetermined position
of a housing with respect to the vibrator device as a reference (as
described in claim 6). This embodiment permits an optimum setting
of the size of the margin volume part in accordance with the size
of the balloon solely simply by aligning the indicator with the
predetermined position of the housing with respect to the vibrator
device to which the elastic tube is to be connected.
[0027] It is preferred that the predetermined position of the
housing is set at the edge surface of an orifice on the inlet side
or in its vicinity thereof and at a position that can be readily
visible from the outside. The indicator can be set in a plural
number at spaced intervals disposed in the direction toward the
base end portion side of the elastic tube from the top end side
thereof (as described in claim 7). In this embodiment, the size of
the margin volume part can be set in an extremely easy and accurate
way in accordance with the size of the balloon simply by confirming
the position visibly.
[0028] In a predetermined path extending from the base end portion
of the catheter main body to the top end of the elastic tube, at
least one air vent valve for venting air within the predetermined
path is provided (as described in claim 8). This is a preferred
embodiment in order to vent the air present in the area extending
from the balloon to the top end of the elastic tube to a thorough
or adequate extent by venting the air from the area most remote
from the balloon, thereby enabling a surer transmission of the
vibration to the balloon.
[0029] The air vent valve can be connected to the top end of the
elastic tube (as described in claim 9). The connection of the air
vent valve is preferred in order to vent the air present in the
area extending from the balloon to the top end of the elastic tube
to a complete or adequate extent by venting the air from the
position most remote from the balloon.
[0030] The air vent valve may comprise a first air vent valve and a
second air vent valve, the first air vent valve being connected to
a path extending from the catheter main body to the elastic tube
and the second air vent valve being connected to the top end of the
elastic tube (as described in claim 10). This embodiment is
preferred in order to thoroughly or adequately vent the air present
within the path to be filled with the heating liquid even in such a
state that the elastic tube is pressed with the roller.
[0031] In order to achieve the above second object, the present
invention adopts the solutions as will be described below, i.e., in
claim 11. The subject matter of claim 11 is directed to the elastic
tube that is structured in such a manner that the tube wall
portions of the elastic tube on the opposite sides can be closely
attached to each other in the radial direction, on the one hand, as
external force is applied in the radial direction from the outside
to constrict or reduce the radial size of the elastic tube and that
they can be recovered elastically to their original positions, on
the other hand, as the external force is released. The elastic tube
can be closed at its top end comprise a connection portion at which
the base end portion of the tube is connected to the catheter main
body. The elastic tube may be provided at its outer peripheral
surface with plural indicators at spaced intervals in the
longitudinal direction thereof, the indicator corresponding to the
size of the balloon in the heating-type balloon catheter device. In
accordance with the above solutions, an elastic tube device can be
provided, which can be used for the heating-type balloon catheter
device as described in claim 1 and have the indicator for setting
the size of the margin volume part is disposed.
[0032] Preferred embodiments on the premise of the above solutions
are described in each of claims 12 to 14, which can provide the
elastic tube device having the plural indicators disposed at spaced
intervals in the area extending from the top end portion side of
the elastic tube toward the base end portion thereof (as described
in claim 12). This preferred embodiment can provide the elastic
tube device as being preferably applied to the heating-type balloon
catheter device as described in claim 7.
[0033] In another preferred embodiment, the air vent valve can be
disposed at either one of the top end or the base end of the
elastic tube in order to selectively vent the air within the
elastic tube to the atmosphere (as described in claim 13). This
embodiment can provide the elastic tube device having the function
of venting the air from the path extending from the balloon to the
elastic tube.
[0034] In a further preferred embodiment, the elastic tube can be
provided with the air vent valves at each of the edge and the base
end portions thereof in order to enable a selective ventillation of
the air present in the elastic tube (as described in claim 14).
This preferred embodiment can provide the elastic tube device
capable of venting the air from the path extending from the balloon
to the top end of the elastic tube.
[0035] In order to achieve the third object, the present invention
adopts the solutions as will be described below, i.e., as described
in claim 15, which comprise: [0036] a housing; [0037] a rotary
shaft held pivotally to the housing; [0038] a guide surface formed
on the inner peripheral surface of the housing in such a way to
enclose the rotary shaft and formed in an arc shape disposed around
the rotary shaft; and [0039] a roller for pressing the elastic tube
in cooperation with the guide surface disposed in such a way to
rotate about the rotary shaft at a position offset from the rotary
shaft; [0040] wherein the number and/or the arrangement of the
roller are/is set to assume a state in which the roller is not
disposed at the position opposite to or facing the guide surface
and the roller cannot press the elastic tube as the rotary shaft is
rotated at one full revolution. The above solution can provide the
vibrator device which can be used appropriately from the
heating-type balloon catheter device as described in claims 1 to
10.
[0041] Other preferred embodiments on the premise of the above
solutions are described in claims 16 et seq. More specifically, the
preferred embodiment comprises one roller and the guide surface set
at an angle in the range of approximately 180 degree round the
rotary shaft as the center (as described in claim 16). This
preferred embodiment can minimize the number of the rollers to only
one. This preferred embodiment can also set the time for applying
pressure to the margin volume part and the time for flowing
backward the heating liquid from the margin volume part to be
approximately equal.
[0042] Another preferred embodiment can comprise two rollers
disposed each at an interval of 180 degree round the rotary shaft
and the guide surface set each at an angle in the range of
approximately 60 degree round the rotary shaft (as described in
claim 17). In this embodiment, the application of pressure and the
backward flowing can be conducted each two times per one full
revolution of the rotary shaft. This preferred embodiment can set
the time for applying pressure for the first time and the time for
flowing backward for the first time as well as the time for
applying pressure for the second time and the time for flowing
backward for the second time per one full revolution to be
substantially equal to each other.
[0043] In another preferred embodiment, the roller system can
comprise two rollers consisting of a front roller and a rear
roller, the front roller being disposed on an advance side in a
predetermined direction round the rotary shaft and the rear roller
being disposed on a delay side in the predetermined direction. The
front and rear rollers may be disposed in the proximity to each
other in the direction of rotation of the rotary shaft and arranged
to assume a position at which they are opposite to or face the
guide surface and a position at which they are not opposite to or
face the guide surface as the rotary shaft rotates one full
revolution. Further, as each of the front and rear rollers are
arranged at the positions opposite to the guide surface, the
distance spaced between the front roller and the guide surface is
set to become somewhat larger than the distance spaced between the
rear roller and the guide surface (as described in claim 18). This
embodiment is preferred in order to impose no crashing external
force (pressure) onto the elastic tube, as compared with the case
where the elastic tube is pressed down once with one roller,
because in this preferred embodiment the elastic tube can be
contracted to a considerable extent with the front roller in
advance before it is thoroughly closed with the rear roller.
[0044] In accordance with the present invention, the magnitude of
vibration energy to be applied to the heating liquid can be
appropriately set in order to comply with the size of the balloon.
Further, the vibrator device as a source of vibration can be
blocked thoroughly from the heating liquid through the elastic tube
so that the device is preferred in terms of cleanliness. Moreover,
the vibrator device allows an effective use of a conventional
roller pump so that the device can be made simple in structure
because it utilizes the rotary motion alone.
[0045] In addition, the present invention can provide the elastic
tube device for use with the heating-type balloon catheter device
of the present invention and the vibrator device appropriate for
use with the heating-type balloon catheter device of the present
invention.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[0046] FIG. 1 is a system diagram showing an example of the present
invention.
[0047] FIG. 2 is a side view in section showing an essential
portion of the case where the orifice of the pulmonary vein is
cauterized.
[0048] FIG. 3 is a view in section taken along the line 3-3 of FIG.
2.
[0049] FIG. 4 is a plan view in partial section showing the detail
of the vibrator device with the elastic tube set thereto.
BEST MODES FOR CARRYING OUT THE INVENTION
[0050] As shown in FIG. 1, a catheter BK is inserted percutaneously
into a predetermined site of the heart H of a patient K from the
outside of the body. The catheter BK is of a heating-type balloon
catheter type and a catheter main body 1 in the form of a tube is
provided at its top end portion with a balloon 2. The balloon 2 is
fitted with a high-frequency heating electrode 3 as a heating means
and a thermocouple 4 as a temperature sensor, as will be described
hereinafter in more detail.
[0051] As shown in FIG. 2, the catheter main body 1 is fitted
therein with a guide tube 5 having a size substantially smaller
than the size of the catheter main body 1. The guide tube 5 has a
length approximately equal to the length of the catheter main body
1 and the top end portion of the guide tube 5 is formed in a form
projecting somewhat from the top end portion of the catheter main
body 1. A guide wire 6 is further fitted to move through the inside
of the guide tube 5.
[0052] The balloon 2 is disposed in such a manner as bridging
between the top end portion of the catheter main body 1 and the top
end portion of the guide tube 5. In the balloon 2, the heating
electrode 3 is disposed in such a manner as winding the guide tube
5, and the thermocouple 4 is further fixed to the guide tube 5.
[0053] FIG. 2 shows the case where the accessory transmission
passage from the pulmonary vein 12, which becomes a cause of atrial
fibrillation, is cauterized with the heating-type balloon catheter
device. More specifically, it is shown therein that the top end
portion of the catheter main body 1, i.e., the balloon 2, is
disposed at the position corresponding to the left ventricle 11,
and the expanded balloon 2 is in annular contact with the pulmonary
vein orifice 12a which is an orifice edge portion to the left
ventricle 11 of the pulmonary vein 12. In FIG. 2, the site of
cauterization is an annular site at which the balloon 2 is brought
in contact with the pulmonary vein orifice 12a and this site is
represented by reference symbol .alpha..
[0054] The wire 13 extending from the heating electrode 3 as well
as a pair of wires 14 and 15 extending from the thermocouple 4 are
disposed to extend through the catheter main body 1 and reach
eventually into the body as will be described hereinafter. The
catheter main body 1 is further provided therein with an air vent
tube 16 for venting the air present in the balloon 2. The air vent
tube 16 is provided in such a manner that the top end portion
thereof has an aperture opening to the inside of the balloon 2 at
its higher position and the other edge portion thereof is open
toward the atmosphere at a higher position of the outside of the
body. Elements 5, 6 and 13-16 are disposed in the catheter main
body 1 as are illustrated schematically in FIG. 3.
[0055] As shown again in FIG. 1, the base end portion of the
catheter main body 1, i.e., the portion disposed outside the body,
is connected to a connecter 20. The connecter 20 comprises a main
passage 21, a first branch passage 22 and a second branch passage
23, the main passage 21 extending on a plane approximately with the
catheter main body 1 in the axial direction as well as the first
branch passage and the second branch passage each being branched
from the main passage 21. The second branch passage 23 is further
branched into two branch passage 23a and 23b.
[0056] The guide wire 6 is disposed to pass through the main
passage 21 of the connecter 20 and extend outside the body. A
hemostatic valve for preventing a backward flow of the blood is
disposed at the site at which the guide wire 6 is led to the
outside of the body from the main passage 22.
[0057] The air vent tube 16 is drawn from the first branch passage
22 and extends toward a higher position (while the site of drawing
the tube is sealed). To the air vent tube 16 is connected a switch
valve 18 which is disposed to be closed after supplying the balloon
2 with the heating liquid, i.e., at the time when vibration is
imparted to the balloon 2, as will be described in more detail
hereinafter.
[0058] The wires 13, 14 and 15 are led from the branch passage 23a
to the outside of the body, and the site of leading outside the
body is sealed. The wire 13 for the heating electrode 3 is
connected to a high frequency (high-frequency voltage) generating
deice 25 from which a wire 26 paired with the wire 13 extends and
is connected to an outside electrode 27 which is brought into
contact with the body surface. By operating the high-frequency
generating device 25 in a state in which the electrode 3 is
disposed at the predetermined site in the body as shown in FIG. 2
and the outside electrode 27 is in contact with the body surface,
high frequency is turned on between the two electrodes 3 and 27 to
heat the heating electrode 3.
[0059] The wires 14 and 15 each extending from the thermocouple 4
are connected each to a temperature measurement device 28 utilizing
a thermometer. A difference of voltage in accordance with the
temperature within the balloon 2 is input to the thermometer 28
through the two wires 14 and 15, and the temperature inside the
balloon 2 can be detected and indicated.
[0060] The branch passage 23b is fitted with a shift valve 31 which
in turn is connected to an elastic tube 40 through an extension
tube 32. A three-way shift valve is used for the shift valve 31
that is arranged to selectively assume a first shift position and a
second shift position, the first shift position being disposed to
connect the branch passage 23b to the extension tube 32 and the
second shift position being disposed to connect the branch passage
23b to a connection orifice 31a opening to the air (at this time,
the extension tube 32 and the branch passage 23b are blocked). In
other words, as the shift valve 31 assumes the second shift
position, on the one hand, a contrast agent and so on is supplied
to the balloon 2 via the branch passage 23b from a syringe 45 to be
connected to the connection orifice 31a. As the shift valve 31
assumes the first shift position, on the other hand, the connection
orifice 31a is closed.
[0061] The extension tube 32 is connected to the elastic tube 40
via the first air vent valve 33 which comprises a three-way shift
valve that in turn can shift the position of the extension tube 32
selectively between a first shift position and a second shift
position in accordance with the shift position. The first shift
position is the position at which the extension tube 32 is
connected to the elastic tube 40 in an airtight way and the second
shift position is the position at which the extension tube 32 and
the elastic tube 40 are connected to an orifice 33a opening to the
atmosphere. The extension tube 32 comprises a pressure-proof tube
which may be made of a material having high rigidity and unlikely
to be deformed by expansion and constriction, yet likely to be
curved in a relatively easy manner. The length of the extension
tube 32 may be set to be as long as approximately 1,300 mm or the
like.
[0062] The elastic tube 40 may be made of a silicone tube for
example, having a length of approximately 300 mm. The elastic tube
40 is set to a vibrator device RP of a roller type. The details of
the vibrator device RP will be described with reference to FIG. 4.
The vibrator device RP comprises a housing 51 and a rotary shaft 52
held pivotally to the housing 51. The housing 51 is provided at its
inner surface with a guide surface G in an arc-shaped form round
the rotary shaft 52. The guide surface G is formed at an angle in
the range of approximately 180 degree (in a generally semi-circular
form) in the direction of rotation of the rotary shaft 52. The
rotary shaft 52 is provided with a roller 53 through a holding rod
54. The roller 53 is fitted by the holding rod 54 in such a manner
as rotating round the axis 53a. This mode enables the roller 53 to
be rotated round the shaft 53a (turn on its axis) and rotated round
the rotary shaft 52 (move in an orbital manner).
[0063] The guide surface G is disposed at a position deviated
outward from a locus of rotation of the roller 53 round the rotary
shaft 52 by a predetermined distance that may be as long as twice
the length of the tube wall of the elastic tube 40. In other words,
in the event where the elastic tube 40 is disposed (set) along the
guide surface G, the elastic tube 40 is caused to completely
constrict or reduce the size of the elastic tube 40, i.e., to be
closed thoroughly in the radial direction (i.e., the tube walls of
the elastic tube 40 opposite to each other are closely attached to
each other) at a position at which the roller 53 is located
opposite to the guide surface (i.e., at an angle in the range of
approximately 180 degree about the rotary shaft 52).
[0064] The housing 51 is provided with an inlet 51a and an outlet
51b. The elastic tube 40 is disposed along the guide surface G and
extends from the inlet 51a and the outlet 51b to the outside of the
housing 51 (i.e., the elastic tube 40 is set in such a state that
it is curved in a generally U-shaped form as a whole). The length
of projection of the elastic tube 40 from the inlet 51a is set to
be short and the first air vent valve 33 is disposed at a position
immediately close to the inlet 51a.
[0065] The portion of the elastic tube 40 projecting from the
outlet 51b constitutes a margin volume part 40A and the length
(size) of the margin volume part 40A is represented by reference
symbol V. The length V of the margin volume part 40A is set
(altered) to become a predetermined length in accordance with the
size of the balloon 2 (indicated by the volume or the diameter
corresponding to the volume). The top end of the elastic tube 40,
i.e., the top end of the portion projecting from the outlet 51b, is
fitted with the second air vent valve 41 which comprises an switch
valve to selectively shift between a state in which the top end of
the elastic tube 40 is closed and a state in which the elastic tube
40 is opened to the air.
[0066] The elastic tube 40 is provided with indicators S1, S2 and
S3 at its outer peripheral surface on the side of the top end
portion thereof. The orifice edge surface 51c of the outlet 51a of
the housing 51 is set at a predetermined reference position
corresponding to the indicators S1 to S2, inclusive. Among the
indicators S1 to S2, the indicator S3 is disposed at a position
closest to the top end of the elastic tube 40 (i.e., the second air
vent valve 41), while the indicator S1 is disposed at a position
most remote from the top end of the elastic tube 40. The indicator
S2 is disposed at a position between the indicators S1 and S3.
[0067] By altering the indicator to be aligned with the orifice
edge surface 51c, the length of the margin volume part 40A can be
altered. A description will be made concerning the setting of the
length of the margin volume part 40A as a specific example. In this
example, the length of the catheter main body 2 is set to 800 mm
(an outer diameter set to 5 mm), a 4.times.8 300-mm silicone tube
is used as the elastic tube 40, a 1,300-mm pressure-poof tube is
used as the extension tube 32 (the diameter is set to be equal to
that of the elastic tube 40), and the length of the guide surface G
(i.e., the length in an angle in the range of approximately 180
degree about the rotary shaft 52) is set to 160 mm. First of all,
in a state of FIG. 4 in which the indicator S1 as a reference
position is aligned with the orifice edge surface 51c, this state
corresponds to the position appropriate for the balloon 2 having a
size as large as 30(p for example (in this case, the reference
symbol V is set to 140 mm for example, when the length of the
margin volume part 40A is represented by reference symbol V). For
example, when the indicator S2 is aligned with the orifice edge
surface 51c, the length of the margin volume part 40 is set to be
shorter than the length as expressed by the reference symbol V (V
being set to 90 mm for example). The position in this case is
appropriate when the balloon 2 has a size as large as 25.sub..phi..
Moreover, when the indicator S3 is aligned with the orifice edge
surface 51c, the length of the margin volume part 40A is set to be
shorter (40 mm for example). The position in this case corresponds
to the position appropriate for the balloon 2 having a size as
large as 20.sub..phi.for example.
[0068] The rotary shaft 52 is driven rotatively in the
predetermined direction of rotation (a motor for rotatively driving
being not shown in the drawing). The predetermined direction of
rotation is defined as a direction in which the roller 53 is
directed from the side of the inlet 51a to the side of the outlet
51b round the rotary shaft 52, that is, as a direction in which it
move in an orbit motion from the base end portion of the elastic
tube 40 (a connection part to the extension tube 32) to the side of
the outlet 51b (the side of the second air vent valve 41).
[0069] The elastic tube 40 is thoroughly deformed by crushing or
flattening the radial size of the elastic tube 40 at a position
where the roller 53 is disposed opposite to the guide surface G
(i.e., the opposite tube walls of the elastic tube 40 are closely
attached to each other), and the side of the base end portion of
the elastic tube 40 and the side of the top end portion of the
elastic tube 40 are blocked on the boundary of the portion whose
size is crushed or flattened. The margin volume part 40 is provided
with pressure in accordance with the movement of the roller 53 in
the predetermined direction of rotation. On the other hand, the
side of the base end portion of the elastic tube 40 is communicated
with the side of the top end portion of the elastic tube 40 at the
position where the roller 53 is not opposite to the guide surface G
because the flattened portion of the elastic tube 40 is recovered
to its original size by the action of recovering elasticity. In
other words, in the event that the flattened portion of the elastic
tube 40 is expanded and returned to its original size, the pressure
applied to the margin volume part 40A is released (i.e., flown
backward) toward the base end portion thereof.
[0070] The heating liquid in the margin volume part 40A pressurized
by applying pressure thereto at the time when the size of the
elastic tube 40 is crushed or flattened in a state in which the
path extending from the elastic tube 40 to the balloon 2 is filled
with the heating liquid is then flown backward toward the balloon 2
as the elastic tube 40 is expanded. The vibration can be
transmitted from the margin volume part 40A to the balloon 2 by
repeating the crushing or flattening of the size of the elastic
tube 40 and the expansion of the crushed or flattened size thereof.
As a result, the heating liquid is stirred to make the temperature
of the heating liquid uniform. Although a larger magnitude of
vibration energy is required for making the temperature of the
heating liquid uniform in the event where the balloon 2 having a
larger size is used, such a large magnitude of the vibration energy
can be obtained by making the length of the margin volume part 40A
larger.
[0071] Although the frequency of vibration is desired in the
highest possible number, the vibration cannot be effectively
transmitted to the balloon 2 if the high frequency is damped on its
way. Therefore, the frequency of the vibration is preferably set to
approximately 2 Hz for example, as in the specific case as has been
described above. In this case, the rotary shaft 52 may be rotated
by two full revolutions per second. It can be noted herein as a
matter of course that, as the the number of rotation of the rotary
shaft 52 is set higher, the frequency of the vibration is made
higher.
[0072] Next, a description will be made of the action of the
construction of the present invention as has been described above.
First, at the initial stage, the shift valve 31 is in a state in
which the branch passage 23b is communicated with the connection
orifice 31a and the shift valve 31 is not connected to the
extension tube 32. In this state, the guide wire 6 is inserted
cutaneously into the body from the outside of the body in such a
state that the top end portion thereof is inserted to some extent
into the pulmonary vein 12 via the left ventricle 11. The catheter
main body 1 can then be inserted into the body (by inserting the
guide wire 6 through the guide tube 5) as it is guided by the guide
wire 6 (in such a state that the balloon 2 is deflated).
[0073] When it is confirmed from the outside of the body by
utilizing a contrast agent to be supplied from the connection part
31a to the balloon 2 that the balloon 2 reaches the left ventricle
11 and it is positioned in the vicinity of the pulmonary vein
orifice 12a, for example, air is sent under pressure from the
connection part 24a to expand the balloon 2. As a result, the
balloon 2 is allowed to come into contact with and press the
pulmonary vein orifice 12a to a strong extent, as shown in FIG. 2.
It is to be noted herein that the shift valve 18 connected to the
air vent tube 16 can be closed upon expansion of the balloon 2.
[0074] From the state of FIG. 2, for example, the balloon 2 and the
catheter main body 1 can be filled with the heating liquid by
supplying the balloon 2 with the heating liquid from the connection
part 31a. Upon supplying the balloon 2 with the heating liquid, the
air can be effectively withdrawn outward from the balloon 2 by the
air vent tube 16 (by opening the shift valve 18), thereby allowing
a smooth supply of the heating liquid to the balloon 2. It is to be
noted herein that, if the air would be left inside the balloon 2
without being withdrawn completely, for example, the air in the
balloon 2 is sucked from the connection part 24a toward the outside
and the heating liquid is supplied again to the balloon 2. This
operation can be repeated as needed.
[0075] Apart from the above procedures, a connection member
comprising the elastic tube 40 and the extension tube 32 is
prepared (to this connection member being connected the air vent
valves 33 and 41). The connection member is filled with the heating
liquid by using one of the air vent valves 33 and 41) and then the
air vent valves 33 and 41 are closed.
[0076] The elastic tube 40 of the connection member filled with the
heating liquid is set to the vibrator device RP. At this timing,
the margin volume part 40A is set to have a length corresponding to
the size of the balloon 2 by utilizing the indicators S1-S3,
inclusive. The extension tube 32 is connected to the shift valve 31
before or after the setting of the margin volume part 40A. The air
remaining in the path extending from the balloon 2 to the elastic
tube 40 can be withdrawn from the air vent valve 33 or 41. Even in
such a state that the elastic tube 40 is pressed down and closed
with the roller 53, the air can also be withdrawn by the second air
vent tube 41 from the top end portion of the elastic tube 40, i.e.,
the side of the margin volume part 40A.
[0077] Once it is confirmed that the path extending from the
balloon 2 to the elastic tube 40 (i.e., the margin volume part 40A
thereof), the high-frequency generating device 25 is operated to
allow the heating electrode 3 to start heating. The operation
status of the high-frequency generating device 25 can be subjected
to feed-back control in order to permit the temperature within the
balloon 2 to reach a predetermined temperature (60.degree. C. for
example), that is, the temperature to be detected with the
thermocouple 4.
[0078] Upon heating with the heating electrode 3, the vibrator
device RP is driven to rotatively drive the roller 54 in the
predetermined direction of rotation. This permits a repetition of
events comprising the application of pressure to the margin volume
part 40A of the elastic tube 40 and the backward flow of the
pressured heating liquid within the margin volume part 40A toward
the catheter main body 1. The vibration of the heating liquid in
the elastic tube 40 is transmitted to the heating liquid within the
balloon 2 through the heating liquid of the catheter main body 1,
thereby stirring the heating liquid in the balloon 2. This makes
the temperature within the balloon 2 uniform as a whole due to the
stirring of the heating liquid by vibration, although the heating
liquid heated to a high temperature with the heating electrode 3
are likely to gather on top of the balloon 2. The pulmonary vein
orifice 12a is cauterized by heating the balloon 2. As the balloon
2 is set to make the temperature uniform as a whole, the pulmonary
vein orifice 12a can be cauterized to a uniform extent over the
full length in the peripheral direction.
[0079] Although the present invention has been described by way of
working examples, it is to be understood that the present invention
is not limited to the working examples and various modifications
and variations are possible as long as they are encompassed within
the scope of the claims. For example, the heating electrode 3 may
also be used as one of conductors for the thermocouple 4 and either
one of the wires 14 and 15 can be removed (for example, Japanese
Patent Application Publication No. 5-293,183 discloses an
embodiment in which the wire of the heating electrode is also used
as one of the wires for the thermocouple). It is further noted that
the mode of cauterization is not limited to an annular
cauterization of the pulmonary vein orifice and the present
invention can also be applied to cauterization of a site of the
heart or body tissues other than the heart.
[0080] The number or disposition of the rollers of the vibrator
device RP may be two or more if there can be attained a state in
which pressure is applied with the roller and a state in which no
pressure is applied at all with the roller. For example, the roller
54 may comprise two rollers disposed at an interval of 180.degree.
in the direction of rotation of the rotary shaft 52, while the
length of the guide surface G extends at an angle in the range of
approximately 60.degree. in the direction of rotation of the rotary
shaft 52. In this embodiment, the margin volume part 40A is
subjected to application of pressure and to backward flow at two
times each as the rotary shaft 52 makes a full revolution. More
specifically, the events consisting of the first application of
pressure (the first application of pressure with the roller), the
first backward flow, the second application of pressure (the second
application of pressure) and the second backward flow occur in this
order while the rotary shaft makes one full revolution. Moreover,
the time required for the application of pressure and the time
required for the backward flow are set each to be substantially
equal to one another.
[0081] The number of the air vent valves may be one or three or
more. For example, it may be disposed only at the edge or at the
base end of the elastic tube 40. Further, the air vent valve may be
disposed in another path connected to the elastic tube 40, e.g., at
an intermediate portion of the extension tube. The elastic tube 40
can be connected to the connecter 20 or the catheter main body 2
without using the extension tube 32. It is not needed to separately
fit the air vent tube 16 (in particular in order to reduce the
outer diameter of the catheter main body 1). In this embodiment,
the elastic tube 40 can be connected to the branch passage 22. The
vibrator device RP can also be used for imparting vibration to a
fluid, particularly liquid, even in the field other than the
heating-type balloon catheter device. The predetermined positions
(reference positions) to be aligned with the indicators S1 to S3,
inclusive, set to the housing 51 may be set, for example, at the
orifice edge surface of the inlet 51a or in the vicinity other than
the orifice edge surface thereof. Moreover, the indicators may also
be disposed at the base end portion of the elastic tube 40. In this
embodiment, the predetermined position to be set to the housing 51
may be disposed at the orifice edge surface of the inlet 51a or in
the vicinity thereof and the one that can be readily visible from
the outside. It can be noted as a matter of course that the
indicators S1-S3, inclusive, may be disposed at an intermediate
portion in the longitudinal direction of the elastic tube 40. In
this embodiment, the above predetermined position may be set in the
vicinity of the guide surface G of the housing 51. Moreover, the
indicator to be set to the elastic tube 40 may be only one while
the housing 51 may be provided with plural predetermined positions
(reference positions) to be aligned with the above one indicator at
a spaced interval along the elastic tube 40 (along the guide
surface G for example).
[0082] The function of one roller can be performed substantially by
two rollers. For example, as shown in FIG. 4, in the event where
the roller 54 is considered as a rear roller, a front roller is
disposed as an auxiliary roller at a position immediately before
this rear roller (the front roller itself rotates round the rotary
shaft 52 (conducts an orbital motion) in substantially the same
manner as the rear roller 54). It is provided, however, that, in
the event where the front roller is at a position opposite to the
guide surface G, the spaced distance from the guide surface G is
set to become somewhat smaller than that from the rear roller 54.
More specifically, the spaced distance from the guide surface G in
the event where the front roller is disposed at a position opposite
to the guide surface G can be set to a distance that can reduce the
radial size of the elastic tube 40 yet cannot close to a full
extent (a distance somewhat longer twice the length of the tube
walls opposite to the elastic tube 40). This setting allows the
front roller to reduce the size of the elastic tube 40, for
example, by approximately a half to two-thirds and immediately
thereafter the rear roller 54 to close the elastic tube 40
completely. As the size of the elastic tube 40 is reduced in
advance by the front roller to a considerable extent in the manner
as described above, even though it is not closed completely, this
embodiment is preferred in terms of application of no crashing
external force to the elastic tube 40, as compared with the
embodiment in which the elastic tube 40 is closed to a full extent
once by only one roller.
[0083] The object of the present invention is not limited to those
as expressed above and encompasses those described impliedly as
substantially preferred or as merits. Further, the present
invention can be expressed also as a heating method.
* * * * *